Bronchoscope cleaning device and method

ABSTRACT

A device and method for cleaning and sterilizing a bronchoscope. A caddy is provided for containing the bronchoscope prior to, during, and subsequent to cleaning and disinfection of the bronchoscope. The caddy may be used to transport the sterilized bronchoscope from the cleaning area to an operating suite, while maintaining the bronchoscope in a cleaned and disinfected state.

The contents of Provisional Application Ser. No. 61/691,471 filed Aug.21, 2012, on which the present application is based and benefit claimedunder 35 U.S.C. §119(e), is herein incorporated by reference.

FIELD OF THE INVENTION

This invention pertains to medical devices and methods generally, and ismore specifically directed to a cleaning device method, and a caddy fora bronchoscope.

BACKGROUND OF THE INVENTION

Bronchoscopy is a technique of visualizing the inside of the airways fordiagnostic and therapeutic purposes. A bronchoscope is inserted into theairways, usually through the nose or mouth, or occasionally through anendotracheal or tracheostomy tube. Using the bronchoscope, the operatorvisually examines the patient's airways for abnormalities such asforeign bodies, bleeding, tumors, or inflammation. Specimens may betaken from inside the lungs. The bronchoscope may comprise optical fiberinstruments with real time video equipment. An exemplary bronchoscope isshown in FIG. 1.

Bronchoscopes of the type shown in FIG. 1 are reusable. Accordingly, thebronchoscope must be properly disinfected and cleaned after use. Thereis a need for a device that will clean and disinfect or sterilize thebronchoscope in a substantially automated process. The device shouldalso provide a means for containing and transporting the cleaned anddisinfected or sterilized bronchoscope for reuse, with no directhandling of the bronchoscope during transport.

SUMMARY OF THE INVENTION

The present invention is a device and method for cleaning anddisinfecting a bronchoscope. A caddy is provided for containing thebronchoscope prior to, during, and subsequent to cleaning anddisinfection of the bronchoscope. The caddy may be used to transport thedisinfected/sterilized bronchoscope from the cleaning area to anoperating suite or other procedure area, while maintaining thebronchoscope in a clean and disinfected state.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exemplary bronchoscope of a type that may be used with theinvention.

FIG. 2 is a perspective view of an embodiment of a cleaning device for abronchoscope.

FIG. 3 is a perspective view of the cleaning and disinfecting device ofFIG. 2, with a bronchoscope in position.

FIG. 4 shows the cleaning and disinfecting device of FIG. 3,demonstrating the caddy containing the bronchoscope being removed fromthe cleaning device.

FIG. 5 shows the caddy with a cleaned and disinfected bronchoscopecontained therein, and capped at each end for transportation for use.

DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 shows a bronchoscope 2 of a type that may be used with theinvention. The invention is not limited to use with the exact structureshown in FIG. 1. The bronchoscope as shown in FIG. 1 has a soft rubbertube 4 that may be passed through the nose. The bronchoscope may beconnected to a video and/or light source. A camera may be mounted to thetop of the bronchoscope in the embodiment shown in FIG. 1.

After use, according to an embodiment of the present invention, thebronchoscope is placed into a caddy 6. FIG. 2. The caddy is preferred tohave a relatively large opening 8 at the top for receiving thebronchoscope. The caddy has an opening in the top portion thereof forreceiving and holding the bronchoscope. According to the embodimentshown in the drawings, the caddy may have a cylindrical top portion forreceiving the bronchoscope. In another embodiment the top portion hasone or more flat surfaces, while maintaining the volume necessary tohouse that portion of the bronchoscope.

The caddy is shown in the drawings as being transparent for illustrationpurposes, but may be transparent, translucent or opaque in use. Atransparent embodiment allows the device to be viewed while in the caddyfor identification purposes, without violating the cleanliness of thedevice.

In a preferred embodiment, in a lower region of the caddy is a lowertube 10 of substantially reduced dimension or diameter from the topportion, according to the embodiment shown in the drawing figures. Thelower tube has a lumen therein that receives fluids from the upperportion. The lower tube has an opening at the bottom thereof todischarge fluids from the caddy.

Between the upper cylindrical portion in the upper region of the caddyand the lower tube portion in the lower region of the caddy is afrusto-conical section 12 which both holds the lower end of thebronchoscope in position, and provides a funnel for channeling liquidand draining the caddy. The frusto-conical section of the caddy is in amid-region of the caddy between the upper region and the lower region.The bronchoscope is held completely within the caddy as shown in FIG. 4,with the top of the bronchoscope positioned below the top edge of thecaddy.

The caddy and bronchoscope are positioned within the cleaning device.The cleaning device may be a cabinet 14. The cabinet may be of any shapeor configuration that will accept the caddy therein. The cabinet shouldbe structured so as to hold the caddy. Holders, brackets or mountssuitable for holding the caddy in position may be provided. In apreferred embodiment, the caddy is held by a bracket of the cabinet sothat the caddy is in a generally vertical position. The bronchoscope ispositioned generally vertically within the caddy.

In a preferred embodiment as shown in the drawing figures, the cleaningdevice has a conduit that branches into a plurality of connectedconduits, each having an outlet. As shown in the drawing figures, thereare three conduits branching from a main conduit 16, each havingoutlets. More or fewer conduits may be used according to the particularapplication and the particular bronchoscope.

The conduits may communicate with a rotary valve 18 to receive liquidsand/or gasses for cleaning or drying the bronchoscope. A valve, such asthe rotary valve, allows a selection between various materials that areforced under pressure through the valve and into conduits. The rotaryvalve may be manually operated to select between various materials, orthe rotary valve may be motorized for selection between variousmaterials, or the rotary valve may be motorized and operated by a timingcircuit that switches the rotary valve in an automatic mode. Other typesof valves and controls for valves may be used to selectively supplymaterials to the conduit on an automatic or semi-automatic basis.

In one embodiment, the cabinet provides a seal 20 to seal the bottomorifice of the caddy, and selectively prevent or allow fluids to exitthe caddy. The seal may be an air bladder that is inserted into thelower tube of the caddy, and the bladder inflated to seal the conduitwhen the caddy is filled with liquid material, and deflated to allow thecaddy to drain as materials are placed into the caddy and thebronchoscope by the rotary valve. The seal may be actuated in acoordinated fashion with the rotary valve to cause the caddy to fillwith liquid material and to drain the liquid material. A drain may beprovided in the bottom of the cabinet for draining liquid material fromthe cabinet.

In use, a bronchoscope that has been previously used in a medicalprocedure, and is in need of cleaning and disinfection, is placed intothe caddy as shown in FIG. 3. Bronchoscopes of the type that are incommon use have multiple ports 22, 24. The conduits are conducted to theports, as shown in FIG. 3. Accordingly, the ends of the conduit shouldhave fittings on the ends that allow the ports of the bronchoscope to beconnected to the conduits. One end of a conduit is shown as positionedin the caddy and below a top of the caddy.

In an exemplary sequence, the seal is actuated to seal the bottom of thecaddy and prevent draining of the caddy, such as by inflating an airbladder. The rotary valve is positioned to cause a cleaning anddisinfecting fluid to flow under pressure into the caddy. The flow ofmaterial continues until the bronchoscope is completely submerged in thecleaning fluid that is present in the caddy. The cleaning fluid alsoflows into the interior of the bronchoscope under pressure, with thecleaning fluid flowing through the conduits into the ports of thebronchoscope. The cleaning fluid remains in the caddy for a sufficienttime to clean and disinfect the bronchoscope.

The seal is then released, such as by deflating the seal, to allow thefluid to flow from the outlet to the bottom of the caddy, and out of thecabinet.

The seal is then actuated to seal the bottom orifice of the caddy. Aliquid rinsing material is provided under pressure through a rotaryvalve and the conduits to also force the rinsing material through theconduits connected to the ports. The rinsing material fills the caddy sothat the bronchoscope is substantially submerged. The rinsing materialremoves the first liquid disinfecting material from the bronchoscope andcaddy, but may also further clean and disinfect the bronchoscope. Thecleaning and disinfecting cycle, and/or the rinsing cycle, may berepeated as desired, or as is necessary to achieve cleaning anddisinfection.

After the bronchoscope is rinsed, the seal is actuated, such as bydeflating the bladder, to allow the rinsing material to drain from thecaddy and the cabinet.

In one embodiment, after the rinsing material is drained from the caddyand the bronchoscope, the rotary valve is switched to communicate with apressurized gas source. The pressurized gas source causes the gas to beforced into the caddy and through the ports of the bronchoscope underpressure, to expedite drying of the bronchoscope. The gas may bepressurized air. The cabinet may provide an elevated temperature toexpedite drying, as long as the elevated temperature is not sufficientlyhigh to damage the bronchoscope. Similarly, the pressurized gas may beof elevated temperature to expedite drying of the caddy and thebronchoscope. The cabinet may incorporate an exhaust fan and appropriatefilters, such as HEPA filters, to reduce the discharge of noxiousmaterials or odors for use in areas without sufficient air exchange. Ina since it will have a self contained fume hood. The cabinet may providetemperature and/or volume and/or pressure monitoring devices to monitorthe liquid materials and/or air in the chamber.

After the bronchoscope is cleaned, disinfected, and preferably dried asdescribed herein, the caddy is removed from the cleaning device. It ispreferred that only the exterior of the caddy is touched as the caddy isremoved, and that the bronchoscope is not touched. The interior of thecaddy, as well as the bronchoscope, are cleaned and disinfected.

Covers are provided for the caddy. A removable top cover such as end cap26 covers the top opening of the caddy. A removable lower cover such assmaller end cap 28 covers the lower opening of the caddy. End caps 26,28 for the upper opening and lower opening of the caddy may be fitted asshown in FIG. 5.

The covers or end caps should also be cleaned and disinfected, so thatthe bronchoscope is maintained in a sufficiently sterile state until itis ready for use. The top cover and lower cover in a clinically sterilecondition after sterilization of the bronchoscope. The top cover andlower cover may be formed of flexible plastic material that provides asnap fit, or the covers and the caddy may be threaded for attachment.The caps should fit so that air is not conveyed through the openings ofthe caddy when the caps are in position covering the openings of thecaddy. The bronchoscope may be transported within the caddy, whilemaintaining the bronchoscope in a sufficiently disinfected/sterile statefor use.

Flow of cleaning materials through, in sequence, the valve, conduit,caddy and drain is such that the exposure of the atmosphere to cleaningmaterials is minimal. The connections of the conduit(s) to the caddy andthe connections of the drain to the caddy should be fittings that do notleak, and the bronchoscope is maintained in a sealed space in the caddythat is not exposed to the environment during the cleaning process. Thedrain is preferred to carry used cleaning materials away from thecabinet in a manner that does not expose the cleaning materials to theatmosphere. Accordingly, there may be no need to provide filtration forthe cabinet. However, in the event that residual material is deemed tobe environmentally detrimental, a filtration system may communicate withthe interior of the cabinet to filter air from the cabinet during andafter the cleaning operation. The filtration system assists in dryingthe minimal amount of residual cleaning material while also removing theresidual cleaning material from the air.

What is claimed is:
 1. A cleaning device for a bronchoscope, comprising: A. a caddy constructed and arranged to receive a bronchoscope that is oriented generally vertically, the caddy constructed and arranged to receive the bronchoscope entirely within an interior or the caddy, the caddy comprising an enlarged top opening and a substantially smaller lower opening, the caddy decreasing in dimension from the large top opening to the substantially smaller lower opening; B. a cabinet, wherein the cabinet is constructed and arranged to receive and hold the caddy in an interior of the cabinet with the bronchoscope in a generally vertical orientation; and C. a conduit having a lumen therein through which a cleaning material is transported into the interior of the cabinet, wherein the conduit is constructed and arranged to connect to and communicate with a lumen of the bronchoscope; D. wherein the cabinet comprises a drain in a lower portion of the cabinet that communicates with the substantially smaller lower opening.
 2. A cleaning device for a bronchoscope as described in claim 1, the cabinet further comprising a valve, wherein the valve communicates with a plurality of fluids and with the conduit.
 3. A cleaning device for a bronchoscope as described in claim 1, the cabinet further comprising a rotary valve, wherein the valve communicates with a plurality of fluids and with the conduit.
 4. A cleaning device for a bronchoscope as described in claim 1, the conduit comprising a plurality of outlets, with each outlet of the plurality of outlets constructed and arranged to connect to and communicate with one of a plurality of lumens of the bronchoscope.
 5. A cleaning device for a bronchoscope as described in claim 1, the cabinet further comprising a valve, wherein the valve communicates with a plurality of fluids and with the conduit, the conduit comprising a plurality of outlets, with each outlet of the plurality of outlets constructed and arranged to connect to and communicate with one of a plurality of lumens of the bronchoscope.
 6. A cleaning device for a bronchoscope as described in claim 1, wherein the caddy comprises a generally cylindrical upper region, and a frusto-conical mid-region.
 7. A cleaning device for a bronchoscope as described in claim 1, wherein the caddy comprises a generally cylindrical upper region constructed and arranged to receive and hold an upper portion of the bronchoscope, a frusto-conical mid-region constructed and arranged to receive and hold a lower portion of the bronchoscope.
 8. A cleaning device for a bronchoscope as described in claim 1, wherein the caddy comprises a generally cylindrical upper region constructed and arranged to receive and hold an upper portion of the bronchoscope, a frusto-conical mid-region constructed and arranged to receive and hold a lower portion of the bronchoscope, and a cylindrical lower region having a substantially smaller diameter than the upper portion, the cylindrical lower region comprising a lumen therein that communicates with the lower opening of the caddy.
 9. A cleaning device for a bronchoscope as described in claim 1, wherein the caddy comprises a removable top cover, the removable top cover constructed and arranged to cover the top opening of the caddy and maintain the bronchoscope in a clinically sterile condition after sterilization of the bronchoscope.
 10. A cleaning device for a bronchoscope as described in claim 1, wherein the caddy comprises a removable top cover, the removable top cover constructed and arranged to cover the top opening of the caddy, and wherein the caddy comprises a removable lower cover, the removable lower cover constructed and arranged to cover the lower opening of the caddy, wherein the removable top cover and removable lower cover are constructed and arranged to maintain the bronchoscope in a clinically sterile condition after sterilization of the bronchoscope.
 11. A cleaning device for a bronchoscope as described in claim 1, further comprising a seal that is positioned in the cabinet, wherein the seal is constructed and arranged to seal the lower opening of the caddy.
 12. A cleaning device for a bronchoscope as described in claim 1, further comprising a seal that is positioned in the cabinet and the seal is constructed and arranged to alternately seal the lower opening of the caddy and unseal the lower opening of the caddy.
 13. A cleaning device for a bronchoscope as described in claim 1, further comprising a seal that is positioned in the cabinet and the seal is constructed and arranged to alternately seal the lower opening of the caddy and unseal the lower opening of the caddy and the seal is actuated by a switch that is external to the interior of the cabinet.
 14. A cleaning device for a bronchoscope as described in claim 1, further comprising a seal that is positioned in the cabinet, wherein the seal is constructed and arranged to seal the lower opening of the caddy, and wherein the seal is an inflatable bladder. 